The Drugs Controller General Of India on Tuesday allowed Serum Institute of India to resume clinical trials of its experimental coronavirus...
The Drugs Controller General Of India on Tuesday allowed Serum Institute of India to resume clinical trials of its experimental coronavirus vaccine being developed along with pharmaceutical company AstraZeneca and the Oxford University, PTI reported. The earlier suspension order, stopping new recruitment for the Phase 2 and Phase 3 trials, has been revoked.
On September 12, AstraZeneca had announced that it has resumed the clinical trials of its vaccine in the United Kingdom after confirmation by the Medicines Health Regulatory Authority that it was safe to do so. The late-stage trials of the vaccine, one of the most advanced in development, was put on hold on September 9 after a study participant developed an unexplained illness. The company said it could not disclose further medical information. In India, Drugs Controller General of India VG Somani had asked Serum Institute for details on the suspension of trials overseas and to explain why the trials should not be suspended in the country until patient safety is verified.
The Serum Institute on Tuesday submitted the recommendations of Data and Safety Monitoring Board and requested permission to restart enrolment for the clinical trials. The DCGI has directed the vaccine maker to take extra care during screening, provide additional information and closely monitor participants...
